The Government Accountability Office (“GAO”) has issued a report focusing on federal agency efforts to educate prescribers and the public about prescription pain reliever abuse and misuse. The report’s title, “Prescription Pain Reliever Abuse: Agencies have Begun Coordinating Education Efforts, but Need to Assess Effectiveness” telegraphs the report’s conclusion. The report evaluates the nine programs to educate current and future prescribers and nine programs to educate target groups within the general public about prescription pain reliever abuse and misuse, noting duplicative efforts and recommending coordination between the multiple agencies and measuring their effectiveness.

The GAO conducted the performance audit of federal efforts to educate prescribers and the public about prescription pain reliever abuse and misuse from December 2010 to December 2011. The report notes at the outset that key measures of prescription pain reliever abuse and misuse increased from 2003 to 2009. “Abuse” and “misuse” refer to using a prescription pain reliever to get high, using a prescription pain reliever for pain relief without a prescription or using a prescription pain reliever but in ways other than as prescribed.

The report summarized the increased problem of prescription pain reliever abuse and misuse through several key measures. The estimated number of emergency visits annually related to prescription pain reliever abuse and misuse increased by 288,000 visits, (142 percent), from 2004 to 2009; annual admissions to substance abuse treatment facilities for prescription pain reliever abuse and misuse increased by 133,000 admissions, (131 percent), from 2003 to 2009; and the annual number of deaths from unintentional overdoses of prescription pain relievers increased by more than 5,000, (83 percent), from 2003 to 2008. Lastly, the estimated number of persons who abused or misused prescription pain relievers increased from an estimated 11.7 million in 2003 to 12.4 million in 2009, an increase of 6 percent.

The report notes that agency officials have suggested that the increase in adverse health consequences that are key measures of prescription pain reliever abuse and misuse are due to the increasing availability of prescription pain relievers, especially higher potency extended-release and long-acting pain relievers. Another factor is the increase in high-risk behavior. High-risk behaviors include combining the prescription pain relievers with other prescription drugs and alcohol as well as inhaling or injecting the pain relievers instead of taking them orally as prescribed.

The report notes that officials from each of the responsible federal agencies opined that more prescriber education about prescription pain reliever abuse and misuse is required. The Food and Drug Administration (“FDA”), National Institutes of Health (“NIH”), and Substance Abuse and Mental Health Services Administration (“SAMHSA”) have implemented different voluntary CME programs to educate prescribers about issues related to prescription pain reliever abuse and misuse. FDA requires manufacturers to develop a CME or CE course for prescribers as part of a Risk Evaluation and Mitigation Strategy (“REMS”) for extended-release and long-acting pain relievers. NIH communicates with prescribers at medical conferences while SAMHSA developed a CME course on prescribing opioids for chronic pain, partnering with local organizations such medical organizations. FDA requires prescribers of certain transmucosal immediate-release fentanyl products to be trained and certified, then re-certified every two years. NIH and SAMHSA are pursuing funding to develop physician clinical support systems that provide educational resources and free mentoring services related to prescribing prescription pain relievers. Lastly, NIH and SAMHSA are developing curricula for medical students.

The report further notes that the Office of National Drug Control Policy (“ONDCP”) with Drug Enforcement Administration (“DEA”), FDA and SAMHSA assistance, “are working to develop a legislative proposal to require all prescribers who request DEA registration to prescribe controlled substances be trained on the appropriate and safe use, proper storage, and disposal of prescription pain relievers as a precondition of registration.” HPM will monitor and report on this legislative proposal.

The report also discusses the various efforts of DEA, FDA, NIH, ONDCP and SAMHSA to educate teenagers, parents, college students and the general public about prescription pain reliever abuse and misuse. The report notes that several of the public education efforts are duplicative of those of other agencies though concedes that the agencies have different constituencies and approaches to the issue.

The report concludes that the agencies have established or plan to establish metrics to assess the impact of only two of the educational efforts, which leaves the agencies “with limited knowledge as to whether such efforts are effective.” The GAO states the agencies should establish metrics to measure the effectiveness of their education efforts. The GAO also believes that the agencies have missed opportunities to share feedback about their efforts, leveraging their resources and coordinating similar efforts. The report concludes that “there is much to be gained from continued and robust coordination among similar education efforts” and that ONDCP occupies a unique position to coordinate similar agency efforts and ensure that agencies do not duplicate efforts. While duplicative educational efforts can reinforce messages, given the limited resources available to government, it is reasonable for agencies to coordinate education efforts aimed at similar constituencies.

The report’s appendices also contain several informative discussions relevant to the prescription pain reliever abuse and misuse issue in the appendices. One section discusses the various abuse-deterrent formulations of prescription pain relievers. A second summarizes DEA’s controlled substance aggregate production, bulk manufacturing and procurement quota system. We would like to see GAO investigate and issue a full report on DEA’s quota process and its impact on these issues.